Abstract
The use of biologic drugs prepared with recombinant technologies is becoming ever more widespread in medicine. New biologics are appearing for established indications, both for malignancies and other conditions and new drugs are being tested for new indications, with the ratio of patients treated with biologics for non-malignant conditions rising steadily.
This trend is set to continue, as the number of biologic drugs in clinical testing is much higher than the number of those already in use. The main issue hampering further spread of biologic treatment are its costs, which means that in many countries, not all patients who could benefit from biologic drugs can be treated by them.
Biosimilar drugs, different versions of biologic drugs, where the patent protection period has run out, could contribute to wider availability of biologic treatment. Biosimilar drugs, unlike normal generics, are never entirely identical to the original molecules - differences in the preparation can for example lead to differences in protein glycolysis and thus differences in pharmacokinetics of these drugs.
Changes to the manufacturing technology can cause new adverse effects even for original biologic drugs, which is why diligent pharmacovigilance is paramount. With biosimilar drugs entering the market, the costs of biologic treatment should go down and in the ideal case, it should become more widely available.
Due to the large numbers of currently used biologic drugs and rising numbers of biosimilar drugs, the situation for doctors who encounter this kind of treatment in their patients (even if they do not always primarily indicate it) is getting confusing. The goal of this monograph is to summarise, in a single publication, the issues regarding production of biosimilar drugs, the legal aspects of it, including the regulation for launching them on the market, the economic aspects of their use and the current situation regarding possible uses of biosimilar drugs for the main indications in the fields of nephrology, haematology, diabetology, rheumatology, dermatology, gastroenterology and oncology.